Prospect: information for the user

Ferroprotina 80 mg oral granule

ferrimanitol ovoalbumin

Read this prospect carefully before starting to take this medication because it contains important information for you

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• Ifyouexperienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. Contents of the package and additional information

Ferroprotina contains the active ingredient ferrimanitol ovoalbumin and belongs to a group of medicines called oral iron trivalent preparations. It is used in adult patients for the treatment of iron deficiency anemia and iron deficiency states. This medicine normalizes altered hematological parameters in iron deficiency states.

Do not takeFerroprotina 80 mg granulated:

• If you are allergic to ferrimanitol, ovoalbumin, or any of the other components of this medication (listed in section 6). Do not take this medication if you are allergic to eggs or egg proteins.
• If you have hemosiderosis and hemochromatosis (iron storage diseases).
• If you have anemia not related to iron deficiency, such as aplastic, hemolytic, and sideroblastic anemia.
• If you have chronic pancreatitis or liver cirrhosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ferroprotina 80 mg.

• If you have or have had gastric or duodenal ulcers, inflammatory bowel diseases, ulcerative colitis, or liver insufficiency.
• If you are taking or will start taking anti-acid medications, tetracyclines, quinolones, calcium salts, or levodopa.

Other medications and Ferroprotina 80 mg granulated

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Ferroprotina 80 mg should not be administered with:

• Tetracyclines or penicillamine, as they may decrease each other's oral absorption.
• Calcium salts, quinolones (ciprofloxacin, etc.), and levodopa, because iron preparations may decrease the absorption of these medications.
• Anti-acids, as they may decrease the absorption of iron preparations.

The administration of any of these medications should be separated from Ferroprotina 80 mg administration by at least 2 hours.

Taking Ferroprotina 80 mg granulated with food and drinks

Ferroprotina 80 mg should not be administered with milk or dairy products.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Your doctor will decide whether to use this medication during pregnancy or breastfeeding.

Pregnancy

No adverse effects on the fetus have been detected in studies with ferrimanitol or ovoalbumin in pregnant women.

Lactation

No data are available on the excretion of ferrimanitol or ovoalbumin in breast milk.

Driving and operating machinery

No signs of impaired ability to drive vehicles and operate machinery have been described.

Ferroprotina 80 mg contains lactose, sucrose, and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains sucrose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

May cause tooth decay.

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially sodium-free.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The recommended dose is 1 tablet per day after the main meal. Pour the contents of the packet into 200 ml of water and shake until a uniform solution is obtained. The solution must be ingested immediately.

If you estimate that the action of Ferroprotina 80 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Ferroprotina 80 mg oral powder than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ferroprotina 80 mg oral powder

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ferroprotina 80 mg oral powder

Your doctor will indicate the duration of treatment with Ferroprotina 80 mg. Do not suspend treatment before, even if you are feeling better, as there is a risk of relapse of the disease.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Occasionally, digestive discomfort (stomach pain, nausea, constipation, or diarrhea) have been described, which usually disappear when the administered dose is reduced or, in the case of suspension of treatment. Black deposits.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Ferroprotina 80 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store Ferroprotina 80 mg in its original packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines at the SIGRE collection point of your usual pharmacy. In this way, you will help protect the environment.

Composition of Ferroprotina 80 mg granulefor oral solution

• The active ingredient is ferrimanitol ovoalbumin. Each sachet contains approximately 600 mg of ferrimanitol ovoalbumin (equivalent to 80 mg of Fe3+).
• The other components (excipients) are: banana essence, ethyl vanillin, lactose, sodium chloride, and sucrose.

Appearance of the product and content of the packaging

Ferroprotina 80 mg is presented in the form of granule in sachets. Each package contains 15 or 30 sachets.

Only some package sizes may be commercially marketed.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet:June 2009

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/